Lots of recall news today, with three companies yanking products over manufacturing problems or safety concerns. The biggest: CSL, the Southern Hemisphere's only flu-vaccine maker, pulled its seasonal influenza shot for children after side effects increased ninefold. The shot is the first seasonal flu vaccine to include the H1N1 pandemic strain.
Melbourne, Australia-based CSL is withdrawing unused doses of Fluvax Junior, which was suspended from use in late April after fevers and convulsions spiked. Some 9 children of every 1,000 given the shot experienced febrile convulsions, when the expected rate was 1 per 1,000, CMO Jim Bishop says in a statement. The company doesn't know why the rate outstripped expectations; lab tests and factory inspection failed to find "abnormalities" that would explain it.
Meanwhile, the big Johnson & Johnson (NYSE: JNJ) recall of children's medicines has roped in another drugmaker. Blacksmith Brands has recalled four of its PediaCare children's cough and cold meds that were made at the J&J factory in Fort Washington, Penn., where manufacturing lapses were found. The recall wasn't prompted by consumer complaints or side-effect reports, the FDA says, but as a precautionary step because of the plant's "serious problems."
And some IV drugs made by India-based Claris Lifesciences are under recall after the FDA received reports of "floating matter" in IV bags of the antibiotic metronidazole and anti-nausea drug ondansetron. Claris-made ciprofloxacin--another antibiotic--is also subject to the recall. The drugs were all made on the same manufacturing line and were sold by Claris, Sagent Pharmaceuticals, Pfizer, and West-Ward Pharmaceuticals.